Clinical Trial Manager

New

Skills

CRO management Data management EDC systems FDA regulations ICH-GCP IRT systems Multi-disciplinary team collaboration Oncology clinical operations Trial monitoring Vendor selection

We are seeking an experienced Clinical Trial Manager/Sr Clinical Trial Manager to oversee global oncology trials (Ph1-3) in compliance with ICH-GCP and FDA regulations. This role involves collaboration with various stakeholders, including global study sites and investigators, to ensure the successful execution of clinical trials.

Key Responsibilities
  • Manage global oncology trials in compliance with ICH-GCP and FDA requirements.
  • Recruit and qualify global study sites and investigators.
  • Participate in vendor qualification, activation, and selection.
  • Oversee study vendors, including CROs, IRT, labs, and imaging services.
  • Monitor enrollment and trial materials, providing updates to management.
Requirements & Qualifications
  • Undergraduate degree in life sciences or allied health fields.
  • 5+ years of experience in oncology clinical operations; Senior level requires 7+ years.
  • Strong management skills across multiple projects and priorities.
  • Experience with CROs, IRT, labs, and ECG/imaging.
  • Knowledge of ICH-GCP, US/ex-US regulations, EDC, and data management.

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Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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